MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL

Catalog Number PWF030F

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fungus (1872); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patients husband said the patient broke out in a rash and had a yeast infection.He also said the packaging for wicks should indicate latex-free on the box, not that it was not made with any natural latex, as that may lead people to believe there was latex in the wick.Per additional information received from complainant on 13-dec-2019 via phone, the patient was prescribed an unknown medication for the yeast infection.She also stated that she was allergic to latex.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.The potential root causes are materials of construction are not biocompatible and material surface is rough, abrasive or uncomfortable.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "contraindications: -patients with urinary retention warnings: -do not use purewick female external catheter with bedpan or any material that does not allow for sufficient airflow.-to avoid potential skin injury, never push or pull the purewick female external catheter against the skin during placement or removal, -never insert the purewick female external catheter into vagina, and anal canal or other body cavities.-discontinue use if an allergic reaction occurs.-after use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Precautions: -not recommended for patients who are: -agitated, combative or unconperative and might removw the purewick female external catheter.-having frequent episodes of bowel incontinence without a fecal management system in place.-experiencing skin irritation or breakdown at the site -experiencing moderate/heavy menstruation and cannot use a tampon.-do not use barrier cream on the perineum when using the purewick female external catheter.Barrier cream may impede suction -not recommended for use on patients who have undergone recent surgery of the external urogenital tract.-always assess skin for compromise nd perform perineal care prior to placement of a new purewick female external catheter.-maintain suction until the purewick female external catheter is fully removed from he patient to avoid urine backflow.Recommendations: -perform each step with clean technique.N the home setting, wash hands thoroughly before device placement.-prior to connecting the purewick female external catheter to hospital wall suction tubing, verify suction function by covering the open end of the suction tubing with one hand and observing the pressure dial.If the pressure does not increase when the line is covered, verify that the tubing is secured, connected and not kinked.-ensure the purewick female external catheter remains in the correct position after turning the patient.Remove the purewick female external catheter prior to ambulation.-properly placing the purewick female external catheter snugly between the labia and gluteus holds the purewick female external catheter in place for most patients.Mesh underwear may be useful for securing the purewick female external catheter for some patients.-assess device placement and patient's skin at least every 2 hours.-replace the purewick female external catheter every 8-12 hours or when soiled with feces or blood.-change suction tubing per hospital protocol or at least every thirty (30) days." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that the patients husband said the patient broke out in a rash and had a yeast infection.He also said the packaging for wicks should indicate latex-free on the box, not that it was not made with any natural latex, as that may lead people to believe there was latex in the wick.Per additional information received from complainant on 13-dec-2019 via phone, the patient was prescribed an unknown antibiotic for the yeast infection.She also stated that she was allergic to latex.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Type of Device: PUREWICK FEMALE EXTERNAL
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9469338
• MDR Text Key: 173188904
• Report Number: 1018233-2019-07973
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741163081
• UDI-Public: (01)00801741163081
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: PWF030F
• Device Lot Number: MYDS3944
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention